Responsibilities include: managing safety investigations, executing and developing processes for safety assessments and surveillance, complaint analysis, interfacing with the Medical Affairs, Regulatory, Clinical Research, and Post-market Vigilance, and Risk Management departments.

Responsibilities include: reviewing, evaluating and investigating complaints relative to the identity, quality, reliability, safety and effectiveness of assigned Surgical Solutions products. Provide clinical expertise in the oversight of products in order to assess patient safety/harm. Responsible for leading a team in the handling/categorizing of complaints to comply with current FDA and international reporting regulations. Duties also include compliance tracking, trend analysis, preparation of Health Hazard Evaluations, preparation of correspondence with government agencies, and reporting to Management.• Evaluates incoming complaint information and maintains it in the electronic database. • Determines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies. • Works closely with the Medical Director of Patient Safety to establish standards for detection of patient harm.• Closely monitors quality, completeness and timeliness of complaint investigations and files. • Reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.• Leads team of product analysts in complaint tracking and safety assessment activities for assigned product group.• Give technical and performance feedback to the QA Analysts directly.• Train, develop and mentor QA Analysts team members.• Participates in team decision making and displays team problem solving/communication skills. • Prepares and presents information in meetings and to upper Management • Takes lead on specific complaint issues and coordinates with other departments to further investigate. • Responds to and tracks requests for additional information from government agencies. • Responsible for compliance requirements for CFR, ISO and other regulations. • Responsible for the review of medical records and other medical documents submitted in relation to complaints.

Partner with District Sales Manager in achieving implant/revenue goals and enhancing customer satisfaction by effectively managing the districts service team. Lead the creation of territory and district service strategies that support and enhance business objectives. Plan, direct, and coordinate district wide operations.•Ensure all activities drive optimal clinical outcomes •Identify service opportunities through the use of analytics and/or field visits •Provide customer education and product training •Trained in device implant and technical follow up skill sets•Oversee training and development of staff•Provide direction to employees regarding the management of inventory/obsolescence, credentialing, expense management, budgets, data privacy, PO pending, and warranty credits•Ensure understanding of and compliance with SOP/GCP/compliance training •Leverage Lean Sigma concepts to alleviate service burden, improve customer business process management and efficiency, and differentiate MDT •Led District Par Pilot, Standardization Par Pilot and mSTAR PO Pending Pilot programs•Serve as SalesForce.com district trainer and resource

Transitioned to adult cardiothoracic and vascular surgical environment. Responsible for circulating, scrubbing and first assistant duties in the Open Heart and Vascular surgical suites. •Served as preceptor to train new nurses and surgical technicians and evaluated their performance in the operating room•Compiled technical training materials for all new hires to team•Responsible for updating physician preference sheets and inventory locations for assimilation into new EMR system

Coordinated schedules for operating room and surgical staff. Oversaw recruiting, hiring, performance reviews and disciplinary actions for 40+personnel. Maintained capital budgets, inventoried/ordered operating room supplies, and improved procedures for maintenance and sterilization of instruments.Responsible for vendor relationships.•Upheld healthcare, nursing and hospital standards•Directed staff training and development. Preceptor for areas of responsibility •Developed extensive training manual for cardiovascular program along with establishment of on-going training pathways for other areas of responsibility•Surgical Services Policy and Procedure Committee•Cerner Implementation Committee

Completed six month didactic and hands on training program for operating room personnel. Prepared pediatric patients for a wide variety of surgical procedures.•Implemented extensive knowledge of operating room procedures and instrumentation to facilitate a positive surgical outcome•Responsible for circulating and scrubbing duties various types of procedures•Selected to train for the facility’s new Pediatric Heart Program

Provided post-operative patient care, treatment, and medical intervention on the pediatric unit.•Preceptor for new hires and nursing students•PYXIS Implementation Committee